Job Purpose

Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of data and management of safety issues, escalating safety concerns to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Focuses on efficiency and effectiveness to meet the needs of patients and healthcare professionals globally. Supports pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure patient safety worldwide. If appointed as a manager (i.e., Team/Group Leader), is responsible for leadership of a team of individual contributors. Line management leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision-making, change management, partnership, and relations management.

Key Responsibilities

Accountable for the product team-level GSK asset benefit-risk profile and benefit-risk management. Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.

• Leads pharmacovigilance and risk management planning, developing strategies for evaluating issues in the clinical matrix.
• Oversees the safety component of global regulatory submissions.
• Demonstrates expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis, and interpretation.
• Ensures quality decision-making and creative problem resolution based on assessment of all relevant supporting and conflicting information/factors.
• Explores positions and alternatives to reach mutually beneficial agreements and solutions.
• Leads safety governance by developing and executing safety strategies for products in clinical development and post-marketing settings.
• Anticipates, detects, and addresses product safety issues (e.g., product incidents) and ensures risk-reduction strategies are implemented appropriately.
• Facilitates safety governance/SRTs by establishing and operating cross-functional teams to address product safety issues and ensure risk-reduction strategies are implemented in clinical study protocols and/or product labeling.
• Represents Global Safety on cross-functional Clinical Matrix Teams and/or Project Teams.
• Leads cross-functional ad hoc teams to address urgent and important product safety issues.
• Authors/participates in updates to written standards (e.g., SOPs) to ensure policies and regulations are adhered to correctly and consistently.
• Accountable for the escalation of issues and communication on safety matters (e.g., GSB, CHSLC, GLC, QPPV).
• Leads presentations on recommendations or safety issues to senior staff members at GSK Senior Governance Committees.
• Represents GSK and contributes to safety-related discussions at meetings with regulatory authorities, external consultants, and licensing partners.
• Leads cross-functional process improvement teams within GSK.
• Contributes to the development of long-term strategies for clinical programs.
• Regularly contributes innovative ideas to address new issues or improve approaches to existing operations.
• Leads inspection readiness and supports audits/inspections as needed.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Requirements

• Health Sciences/Health Care Professional degree required (e.g., BSc, MS, PhD, RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
• Advanced experience in the Pharmaceutical or Biotech industry working in Medical Affairs, Pharmacovigilance, Drug Safety, or a related field.
• Experience leading and managing team

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Preferred Qualifications

• Medical Doctor (physician) preferred (or equivalent, e.g., veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.
• Experience with Vaccines
• Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.
• Experience working in larg